Brief Title
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
Official Title
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
Brief Summary
The purpose of this post-marketing clinical use database surveillance is to observe the frequency, type, and degree of adverse device effects and adverse events in order to assure the safety of the medical device, and to collect safety and efficacy information for evaluating the results of its clinical use.
Detailed Description
The Surveillance will be conducted per the standards required by the Ministry of Health, Labour and Welfare (MHLW) and in the standards for post-marketing surveillances and studies [except for those defined in the Ministerial Ordinance on Good Clinical Practice for Medical Devices (MHLW Ordinance No. 36, 2005)] based on Paragraph 4, Article 23-2-9 (including application mutatis mutandis per Article 23-2-19 of Revised PAL) of the Law on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices, etc. (Law No. 145, 1960, hereinafter referred to as "Revised PAL") by the Marketing Authorization Holder or accredited foreign manufacturer of a medical device defined in Paragraph 1, Article 23-2-5 of Revised PAL.
Study Type
Observational [Patient Registry]
Primary Outcome
The rate of major complications through 180 days after an attempted Piccolo device implant
Condition
Patent Ductus Arteriosus
Intervention
Amplatzer Piccolo Occluder
Study Arms / Comparison Groups
Amplatzer Piccolo Occluder
Description: Amplatzer Piccolo Occluder device implant
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
70
Start Date
April 1, 2020
Completion Date
May 31, 2025
Primary Completion Date
October 31, 2022
Eligibility Criteria
Inclusion Criteria: The device is used to percutaneously close the PDA of a patient who meets all of the following: - PDA ≤4 mm in diameter - PDA ≥3 mm in length - Weight ≥700 g Exclusion Criteria: - Age <3 days - Coarctation of the aorta - Left pulmonary artery stenosis - Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension - Thrombus in the implant site, or sign of venous thrombus in a vessel in which the occluder is inserted and delivered - Endocarditis, or infection that can cause bacteremia - Allergic or potentially allergic to nickel
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
, +81-3-3524-1792, [email protected]
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT04371081
Organization ID
ABT-CIP-10290
Responsible Party
Sponsor
Study Sponsor
Abbott Medical Devices
Collaborators
Japanese society of Congenital Interventional Cardiology
Study Sponsor
, ,
Verification Date
April 2020